Decreasing Unnecessary Antibiotics Prescribed for Possible Pneumonia Despite Normal Respiratory Rate and Oxygenation

NCT05172791 | Completed

• 1 other identifier: 2021p002282
• Study Type: interventional
• Target: 643
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to decrease unnecessary antibiotics prescribed to hospitalized patients for possible pneumonia by flagging patients with respiratory rates and oxygenation levels within reference ranges given prior data suggesting that discontinuing antibiotics in this population is safe. Patients will be randomized to 3 arms: 1) usual care, 2) electronic alert, or 3) pharmacist outreach.

Conditions

Pneumonia

Keywords

antibiotic stewardship; pneumonia

Outcome Measures

Primary Outcomes (1)

• Duration of antibiotics prescribed for pneumonia

  Duration of antibiotics prescribed for pneumonia

  Number of days of antibiotics given during hospitalization plus number of days of antibiotics for pneumonia on discharge prescriptions, up to 30 days

Secondary Outcomes (8)

• Antibiotic-free days in the 30-days post-randomization

  30-days post-randomization

• Days from randomization to discharge

  Duration of hospitalization, up to 90 days

• Hospital length of stay

  Duration of hospitalization, up to 90 days

• In-hospital mortality

  During initial hospitalization with pneumonia, up to 90 days

• Readmissions within 30-days of randomization

  30-days post-randomization

Study Arms (3)

Usual care

NO INTERVENTION

Clinical teams will decide on antibiotic duration for patients with possible pneumonia without external prompting

Electronic alert

EXPERIMENTAL

An electronic alert will be displayed within the electronic medical record of eligible patients that notes that the patient's respiratory rate and oxygenation are within the normal range and will advise stopping antibiotics prescribed for possible pneumonia

Behavioral: Antibiotic stewardship messaging

Pharmacist

EXPERIMENTAL

Pharmacists will contact the treating teams of eligible patients to note that the patient's respiratory rate and oxygenation are within the normal range and will advise stopping antibiotics prescribed for possible pneumonia.

Behavioral: Antibiotic stewardship messaging

Interventions

Antibiotic stewardship messaging BEHAVIORAL

Counseling regarding antibiotics for patients prescribed antibiotics for possible pneumonia despite respiratory rates and oxygenation levels within normal ranges

Electronic alert; Pharmacist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients admitted to Brigham and Women's and BWH Faulkner Hospitals and prescribed antibiotics with a stated indication of pneumonia who have a median respiratory rate of ≤20 and oxygen saturation of ≥95% without supplemental oxygen sustained for at least 24 hours.

You may not qualify if:

• Patients under 18 years old, patients on transplant and oncology services, patients who are pregnant, patients in an intensive care unit, patients with cystic fibrosis or bronchiectasis, patients on immunosuppressive medications, and patients with positive blood cultures (other than common skin contaminants)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Brigham and Womens Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Michael Klompas, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 29, 2021
• Study Start: July 11, 2022
• Primary Completion: July 10, 2024
• Study Completion: October 8, 2024
• Last Updated: November 21, 2025

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)